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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06131853
Other study ID # 2023/11.09
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2023
Est. completion date December 4, 2023

Study information

Verified date January 2024
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to investigate the effects of prostate cancer on patients' physical activity, kinesiophobia, fatigue and functionality. This research is a prospective study to be conducted on volunteer individuals between the ages of 40-75. People diagnosed with prostate cancer (study group) and healthy adults who have not been diagnosed with prostate cancer before (control group) will be included in the study. The demographic characteristics, physical activity levels and quality of life of all individuals participating in the study will be evaluated with an online form. In demographic data, physical, sociodemographic data such as age (years), height (cm), body weight (kg), body mass index (kg/m2) and disease-specific information will be recorded. Physical activity level will be measured with the International Physical Activity Survey short form (UFAA), fatigue with the Functional Evaluation of Chronic Disease Treatment-Fatigue Questionnaire, fear of movement with the Causes of Fear of Movement Questionnaire, and quality of life with the Functional Evaluation of Cancer Treatment-Prostate Version questionnaire (KHTFD-Y).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 4, 2023
Est. primary completion date November 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - (for prostate cancer-study group) - Being between the ages of 40-75 - Want to participate in the study - Being able to read and write - Being diagnosed with prostate cancer by a specialist physician, - Being able to provide their mobility independently, - (for healthy controls - control group) - Being between the ages of 40-75 - Not having any previous cancer history and not having undergone cancer surgery - Volunteering to participate in the study Exclusion Criteria: - Those with a previously known or accompanying diagnosis of dementia - Not wanting to participate in the study - The individual has a disease that may prevent him or her from understanding and completing the survey. - Illiterates - Those who do not want to participate in the research voluntarily - Having active metastasis - Having undergone chemotherapy and radiotherapy in the last 6 months

Study Design


Intervention

Other:
survey evaluation
assessment of physical activity, fatigue, fear of movement, and quality of life

Locations

Country Name City State
Turkey Selcuk University Konya Selcuklu

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary International Physical Activity Survey short form The short form consists of 7 questions. The form provides information about the frequency and time spent in walking, moderate physical activity, and vigorous physical activity. 10 minutes
Primary Functional Assessment of Fatigue Chronic Disease Treatment-Fatigue Questionnaire It consists of 13 questions that evaluate the level of fatigue that occurred during daily activities in the last 7 days. Scoring varies between 0-52. High scores indicate less fatigue. 10 minutes
Primary Reasons for Fear of Movement Questionnaire It allows the causes of kinesiophobia to be identified and both biological and psychological causes to be determined separately. The average of the scores obtained from the biological and physiological subscales gives the total score from the survey. A 5-point Likert scoring (1 = Totally disagree, 5 = Completely agree) is used in the scale. An individual's high score from the survey indicates that he/she has more fear of movement. 10 minutes
Primary Functional Evaluation of Cancer Treatment-Prostate Version questionnaire It consists of 13 questions that evaluate the level of fatigue that occurred during daily activities in the last 7 days. Scoring varies between 0-52. High scores indicate less fatigue. 10 minutes
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